(30 days)
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .
The intended for use of this over-the-counter device is for age 16 and above.
Full Automatic (NIBP) Blood Pressure Monitor
I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding acceptance criteria, study details, and ground truth establishment for the HL168D Non-Invasive Blood Pressure Monitor. The document is a 510(k) clearance letter from the FDA, which confirms substantial equivalence but does not describe the specific performance studies in detail.
The letter mentions that the device "Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method." It also states "The intended for use of this over-the-counter device is for age 16 and above." However, it does not provide quantitative acceptance criteria for blood pressure and heart rate measurements, nor does it present the results of specific studies against such criteria.
Therefore, I cannot provide the requested table and detailed responses based on the input document.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).